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AHLA's Speaking of Health Law
Gender Affirming Care Updates: Skrmetti, Federal Actions, State Developments, and Provider Responses
Adam Laughton, Shareholder, Greenberg Traurig LLP, speaks with Jennifer Nelson Carney, Member, Epstein Becker & Green PC, about the current landscape of gender affirming care. They discuss the Supreme Court’s June 2025 decision in Skrmetti; the executive orders, memos, agency activity, and proposed legislation at the federal level; how states are reacting to these federal actions and enacting their own legislation; and how providers are responding. From AHLA’s Physician Organizations Practice Group and Women’s Leadership Council.
Watch the conversation: https://www.youtube.com/watch?v=JlQqrJw0oCk
Learn more about AHLA's Physician Organizations Practice Group: https://www.americanhealthlaw.org/practice-groups/practice-groups/physician-organizations
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SPEAKER_02:Hello, everyone, and welcome to this AHLA podcast. This is the update on gender-affirming care. This is a part two from our top 10 podcast earlier this year talking about various developments in gender-affirming care in 2025. My name is Adam Lawton. I'm a shareholder at Klingberg Tarik in Houston, Texas. My practice focuses on health care transactions and regulatory issues. I'm also vice chair of the Physician Organizations Practice Group for AHLA. And today we'll be talking with Jenny Nelson Carney about various things that have happened during the first eight or nine months of this year with regards to gender affirming care. I think we ought to acknowledge that this area is rapidly changing. So with that, I'd like to introduce our guest today, Jenny Nelson Carney. Jenny, can you introduce yourself?
SPEAKER_01:Sure. Thanks so much, Adam. As Adam said, I'm Jenny Nelson Carney. I'm a partner and a health lawyer at Epstein Becker and Green, and I'm also chair of the AHLA Women's Leadership Council. I'm really happy to be here and appreciate AHLA giving us an opportunity to talk about continuing developments in the gender-affirming care space.
SPEAKER_02:Thank you, Jenny. So we spoke earlier this year, like I said, I believe it was around March. It was very early into the new administration. And we talked a lot about various things that were happening in gender-affirming care. We'll revisit those. But just to set a basis for this discussion, when we say gender-affirming care, how would you define that or how should we define that in this discussion?
SPEAKER_01:Yeah, I'm glad you asked that. I think it's always an important level setting when you're discussing gender care for transgender people, because I think that there is still confusion as to what that means. And it's important to know that gender-affirming care is an umbrella term that covers a range of medical and non-medical interventions used to support individuals where there's a conflict between the individual's gender identity and the gender that they were assigned at birth. Most of the public discussion of gender- or sometimes publicly it's referred to as gender transition care, is specific to surgery and medications, medications like puberty blockers and hormone therapy. But it's important to keep in mind that gender affirming care is much broader than that and includes things like social affirmation, which is changes to appearance and names and pronouns, as well as legal affirmation, which is changes on legal documents to those same things, gender and name. So clearly some forms of gender affirming care are easily reversible, like social affirmations, and others such as the surgical procedures are not. When we last spoke in our previous podcast, we talked a lot about the fact that most of the restrictions on gender affirming care have been focused on preventing minors, so the children, people under 18, from accessing gender affirming care. But we are starting to see some increasing governmental activity aimed to restrict gender And this continues to be an important and relevant topic for our healthcare providers because there are approximately 2.8 million people in the United States, ages 13 and older, who identify as transgender. And that's actually a new data point since our last podcast recording. We just reviewed a report from the Williams Institute at the UCLA School of Law last month, and 2.8 million is an increase in the number. number from what we reported in March. And it's about 1% of the U.S. population in that age frame. So it's certainly a significant number of people seeking medical care.
SPEAKER_02:That is a lot of people. I have not heard that number, but that's actually a tremendous amount of people when you think about it. Across the United States, if there's that many people, everybody's going to know someone who's experiencing that or is who's affected by these things that we're discussing so one of the things that we discussed quite at length uh during our previous podcast was this uh skirmetti case that was in front of the supreme court and i think since we spoke there's been a decision so do you want to talk about where that case went and then what the fallout has been from from that decision
SPEAKER_01:Sure. So just as a reminder, the Scarametti case was brought by families of transgender minors and revolved around the question of whether a specific Tennessee law, which we'll refer to as Senate Bill 1, violates the Equal Protection Clause of the 14th Amendment of the U.S. Constitution. Senate Bill 1 prohibits all medical treatments intended to allow a minor to identify with or live as an identity inconsistent with their sex. And it also, importantly, prohibits prohibits medical care to treat discomfort or distress from a discordance between their sex and asserted identity. And as we discussed on our last podcast, the U.S. Court of Appeals for the Sixth Circuit had upheld Tennessee's ban, upheld Senate Bill 1. And so then it was appealed to the Supreme Court. The Supreme Court has indeed issued a decision in this case. We got a decision in June, which just earlier this summer. The opinion was by Chief Justice Robert It was a 6-3 vote, and the opinion said that Tennessee's law prohibiting certain medical treatments for transgender minors is not subject to heightened scrutiny under the Equal Protection Clause of the 14th Amendment and satisfies rational basis review. a governmental action as long as it is rationally related to legitimate government purpose. And that's what they found here. So that was a significant case. It, um, gave significant, um, I, I think that the states that were, have been marching down the road to limit gender affirming care, this was a signal to them that, that those laws are likely to be upheld as constitutional. And we've already seen influence from this case, uh, in, um, Other legal cases, and I'll highlight one in Arkansas, their General Assembly had passed a law to prohibit healthcare professionals from providing gender transition procedures to minors and to prohibit those providers from referring minors for transition procedures. So even if they were not providing them, they prohibited the actual referral saying, okay, well, you can go over here and get it, even if I can't give it to you. So a group of four minors living in Arkansas, along with their parents And then several health care providers sued to enjoin enforcement of this law. The district court ruled in their favor, finding that the law violated both the First Amendment and the Equal Protection Clause and Due Process Clause of the 14th and issued an injunction. But then the state AG and the medical board appealed and the Eighth Circuit, relying in part on the Scrimetti decision we just discussed, reversed the lower court and upheld the ban on care. So we expect to see more cases like that in Scrimetti. METI continue to be cited as a basis for decisions.
SPEAKER_02:And one of the other topics I recall is, you know, even in the very early days of the new administration, you know, starting January 20th, and by the time that we reported, there had been a lot of signals coming out of the administration, a lot of talk about the ways that they were going to push back on gender from here, push back on developments in this area. So what sorts of actions have we seen from the federal government with regards to to gender-forming care.
SPEAKER_01:Well, Adam, buckle up because we have seen a lot of activity since that time. I'm going to take us back to our previous podcast where we spent a lot of time dissecting the two executive orders that were issued in January as they were really the starting point for the federal government's activities. And so just to quickly recap, we had the executive order titled Defending Women from Gender Ideology, Extremism and Restoring Biological Truth to the Federal Government, which basically said it's the policy of of the U.S. to recognize just two sexes, male and female, and that those are not changeable. And it directed federal agencies to enforce laws protecting men and women as biologically distinct sexes and to use the term sex and not gender, and also prohibited the federal government from expending federal funds to promote gender ideology. So that was the one, the Defending Women EO. And then the other EO, there were lots of executive orders, but these were the two that are particularly relevant to gender-affirming care. The second one was titled Protecting Children from Chemical and Surgical Mutilation. And this is the one that has the most significant impact on health care providers. This executive order directed the federal agencies to take appropriate steps to ensure that institutions receiving federal research or education grants, which most medical schools and hospitals, that they need to end the chemical, and this is a quote, chemical and surgical mutilation of people under 19 years of age. So it also turned terminated coverage for certain gender-affirming care. Government provided medical benefits, ordered Health and Human Services to withdraw its March 2022 guidance on gender-affirming care, civil rights, and patient privacy, and to issue new guidance protecting whistleblowers who take action related to ensuring compliance with the EO. And it also ordered the DOJ, the Department of Justice, to prioritize enforcement of an existing law prohibiting female genital mutilation. So at At the time that we recorded the last podcast, there was a lot of consternation amongst medical providers. What does this mean? Do we have to stop right now? Are these directives to us? Are these directives to the agencies? Which the latter is true, directives to the agencies. But it was a good indication of what was to come. And so since that time, we've seen incredible action from the White House and agencies. And we could really spend hours discussing each one and the impact that they may have, and I know I and many healthcare lawyers have done so, but for purposes of our podcast today, since we don't have hours and hours to discuss, I'm just going to give an overview of the actions that we've seen in a chronological order just to give our listeners an idea of what's been happening. So on our last podcast, we discussed that we had started to see some of the actions. There was a CMS letter issued to healthcare providers on March 5th that was quickly followed by a letter from HRSA to hospital and and a letter from SAMHSA to colleagues and grantees, all really reiterating the things that you heard in the EO. So since that time, we first saw on April 11th, CMS sent a letter to state Medicaid directors reminding states that Medicaid programs have a responsibility to ensure that payments are consistent with efficiency, economy, and quality of care, and to remind states that there are longstanding federal Medicaid regulations prohibiting federal funding for coverages of services whose purpose is to permanently render certain populations including children incapable of reproducing so clearly they're focused here on certain surgical procedures related to gender affirming care a few days later then health and human services announced an online complaint portal so anyone can just log online to this complaint portal and report chemical and surgical mutilation of children And if you look at it, it requests very specific information about healthcare providers that may be providing this care, names and addresses and types of care. And it was, along with that, HHS published guidance to protect whistleblowers who make such reports. So that was pretty significant and certainly of note to healthcare providers who provide care in this space. A few weeks later, Attorney General Bondi issued a memo to specific agencies heads entitled Preventing the Mutilation of American Children. You see the theme that we keep hearing from the agencies. This memo was pretty detailed and included a five-part plan, which included enforcement of existing laws outlying female genital mutilation, which was also referenced in the executive order. Second, investigations of the Food, Drug, and Cosmetic Act and False Claims Act, holding accountable medical providers Thank you so much. the AG called Junk Science, which was largely the guidelines from WPATH, which is the World Professional Association for Transgender Health. We talked about that a little bit in our previous podcast. Fourth was establishing a federal and state coalition against child mutilation. And fifth, promoting new legislation protecting children. And we're going to talk a little bit more about that in a minute. But AG Bondi's memo was extensive and laid out, here's where we're going and we have indeed seen agency action for each part of this five-part memo that she said this is what DOJ, where we're headed. So very significantly at the beginning of May, Health and Human Service issued a lengthy report. It was over 400 pages entitled Treatment for Pediatric Gender Dysphoria, Review of Evidence and Best Practices. And the report really challenged the validity of the existing gender affirming care model of care, suggesting that it lacks scientific and medical support, and spent a lot of time discussing what they deem irreversible risks associated with pediatric medical transition. The report also recommended psychotherapy as a non-invasive alternative to endocrine and surgical interventions for the treatment of gender dysphoria. But I will say that the report has received really significant criticism for having both Both anonymous authors, which you don't typically see in a report like this, and not being subject to peer review, which is a really surprising factor. So the report really has come under some significant scrutiny. Later in May, we saw a memo from the Deputy Attorney General Todd Blanch focused on use of the False Claims Act against those who defraud the United States by taking its money while knowingly violating civil rights. and announcing a formation of a civil rights fraud initiative to be co-led with both the DOJ and all the 93 U.S. attorneys' offices. So although this memo did not specifically call out gender-affirming care, recall that the memo from A.G. Bondy discussed use of the False Claims Act as one prong of the DOJ's plan to prevent mutilation of American children, and so it's clear that this memo from the Deputy Attorney General General was in line with that and focused on the same priorities. At the end of May, we saw a letter from CMS Administrator Dr. Oz to unnamed recipients entitled Urgent Review of Quality Standards and Gender Transition Procedures. And his letter cited the HHS report, the lengthy HHS report that I referenced, and expressed serious concerns with medical interventions for gender dysphoria in children. So this letter, though, was pretty significant because it requested that the recipients of the letter submit a set of documents and data to include policies, procedures, protocols, any reports of adverse events and financial data for all pediatric sex trait modifications performed at the recipient's institution and paid in whole or in part by the federal government. So this was very concerning to providers. And there was a lot of questions of, this is an expansive request, and what are they going to do with this information? And what does this mean for us? Are we a target? That same day, late in May, Health and Human Secretary Kennedy sent a letter addressed specifically to healthcare providers, risk managers, and state medical boards, advising them to read with care the HHS report, the lengthy 400-page report, and to update their treatment protocols accordingly. The letter also discuss protections for whistleblowers, again, who make reports concerning what they deem harmful interventions for minors. So you can see the themes. We've got them coming from all different aspects of these agencies. It's, you know, tell us what you've been doing. Have you been using federal funds for it? And encouraging whistleblowers to report. So then in June, we continue to see activity. Assistant Attorney General Brett Shumate issued a memo to all Civil Division employees to set forth a set of priorities for a civil rights fraud initiative that was established in the Blanche memo that I referenced. The new memo from Shoemade stated that the Department of Justice would use all available resources to prioritize investigations of doctors, hospitals, pharmaceutical companies, and any other appropriate entities. It noted that the civil division will aggressively pursue claims under the False Claims Act. So we keep hearing the False Claims Act. That's going to be a tool to be used against health care providers that billed the federal government for permissible services and gave the example of providers that attempt to evade state bans, so state law bans, on gender dysphoria treatment by knowingly submitting claims to Medicaid with false diagnosis codes. So the government's very much on the lookout for that type of activity. And relatedly, a few weeks later, DOJ and HHS then announced a joint effort called a False Claims Act Working Group. So a lot of activity in the false claims space We also saw at the end of June, after some notice and comment rulemaking, CMS, the Center for Medicare and Medicaid Services, issued the Affordable Care Act marketplace final regulations prohibiting coverage of sex trait modification as an essential health benefit for all beneficiaries, not just minors, starting in plan year 2026. And then in July, we saw the Federal Trade Commission, the FTC, hold an all-day workshop intended to help So this was interesting because it was perhaps an example of an unexpected agency involvement. I don't think when we were thinking about where restriction on gender affirming care would go that we would necessarily think that the FTC would take the lead, but their attention is focused on the potential for deceptive advertising. and fraudulent and coercive practices. And so that's how they're viewing this. And their workshop, they had involvement of patients who had transitioned at one point and may have detransitioned and families and lots of testimony along that line. The same day of that FTC workshop, the Department of Justice announced in a press release that it had issued more than 20 subpoenas on hospitals and doctors that provide gender-affirming care for minors. And we were able to see one of those subpoenas publicly in a court filing that gave us insight into the extreme breadth of the request in that subpoena. The subpoena requested personnel files for all executives, management, board members, employees, contractors, and affiliates authorized to prescribe medications or perform medical evaluations, as well as employees, contractors, and affiliates engaged in any billing activities surrounding that care. The DOJ requested guidance, documentation, and communications related to coding and billing of gender affirming care, correspondence and contracts with manufacturers of puberty blockers and hormones, documentation identifying each patient who was prescribed puberty blockers and hormone therapy to include things like name, date of birth, social security number, address, parent guardian information, and documents regarding informed consent, adverse events, and the safety of puberty blockers and hormones. So incredibly expansive request. I mean, people were really shocked at the level of detail that the subpoena, the subpoenas were requesting. So and as Adam mentioned, there has been a lot of continuing activity in this space. And just before we recorded this podcast today, we got word that a U.S. district judge rejected one of those DOJ subpoenas that had been issued to a pediatric hospital, which is a significant rebuke to the administration's efforts in this area. So we're aware that there are challenges to other outstanding subpoenas, so we'll be closely watching this area for follow-up. The FTC also, following its day-long session, launched a public inquiry to better understand how consumers may have been exposed to false or unsupported claims about gender-affirming care, especially as it relates to minors, and to gauge the harms consumers may be experiencing. And so So as part of that inquiry, the FCC issued a request for comments, which as of the recording of the podcast today had received about 6,600 comments and was still open for comment submission. So we expect to see more in that space. We saw in August, the U.S. Office of Personnel Management issuing a memo indicating that the beginning in 2026, all federal employee health plans will be barred from covering gender affirming care. And then just recently on September 3rd, the DOJ proposed legislation to protect children from gender mutilation. The proposed legislation is titled the Victims of Chemical or Surgical Mutilation Act, and it prohibits healthcare professionals, including physicians, hospitals, and clinics from participating in chemical and surgical mutilation of a child. Interestingly, it also creates a private right of action for children and the parents of children whose healthy, this is a quote, healthy body parts have been damaged by medical professionals practicing chemical and surgical mutilation. And the legislation specifically allows for an action to be brought the latter of either within 25 years from the date of the 18th birthday of an individual subject to this chemical or surgical mutilation as a child, or within four years from the time the cost of detransition treatment is incurred, whichever one is later. So it's It's a very lengthy statute of limitations. Finally, I'll note that we have been waiting, expecting a proposed rule from CMS, which would prohibit hospitals enrolled in the Medicare program from providing gender affirming care to minors. The expectation is that this proposed rule will be a condition of participation known as a COP. And the COPs just generally are a set of federal regulations that apply to healthcare organizations, including hospitals. And in order to participate in Medicare and Medicaid, hospitals must comply with the COPs and failure to comply can result in termination of a provider agreement with CMS, which is generally felt to be vital to the existence of the hospital. So the COPs have established standards for quality safety operations and the rights of patients, but have not been previously used to ban a specific medical procedure or type of care. So this would be a new use for a COP if we do end up seeing a proposed rule COP. So that was a lot, Adam, but you can see that the The federal government has continued to take significant action under this administration's priority, and we expect to see that continue.
SPEAKER_02:Well, I definitely see what you mean when you say, well, you know, if we wanted to talk at length about any of this, we could talk for hours, because any one of those things could have been an hour-long discussion. And the dynamic, and it's certainly not just this administration, but every past administration when it comes in, we know the dynamic. Federal government does something, and then some state or coalition of states jumps in to block it, either in court or to take some other action to essentially blunt or nullify the effect of that. So what sort of responses are we seeing from states with regards all these federal actions.
SPEAKER_01:Yes, yes, you're right. So in early August, we saw 16 states plus the District of Columbia file suit against the president, Attorney General Bondi and the DOJ. The lawsuit challenges the executive order, the mutilation executive order and DOJ actions that aim to eliminate the provision of medically necessary health care to transgender individuals. And they say by intimidating providers into ceasing care through through threats of civil and criminal prosecution under laws unconnected to lawful provision of this care. So that's what the lawsuit is focused on. So we're watching that case. It's relatively new, but that'll certainly be instructive to see what happens there. I will say we're still watching the two cases that we discussed in our first podcast, the one that's in the District Court of Maryland, PFLAG versus Trump, and the one in the Western District of Washington, State of Washington versus Trump, both of which continue and have state involvement, either as parties or MEG. And then to your broader question about state involvement, we've also seen a lot of state law activities, just specific to state laws. And I'll highlight a few recent examples from August. One in Massachusetts in early August, the Massachusetts governor signed an updated shield law to strengthen protections for patients and providers. It prevents disclosure of sensitive data. So there's physician's name and prohibits Massachusetts state or local authorities from cooperating with any federal or out-of-state investigation into health care services that are legally protected in Massachusetts, which is why it's known as a shield law. So these protections, this law is, the protections are broader than gender affirming care. They're not just specific to gender affirming care, but clearly intended to include protections there. Then we saw later in the month in Michigan, the Michigan Attorney General issued a warning to Michigan healthcare providers and patients, reminding those providers that refusing healthcare to a class of individuals based on their protected status, such as withholding the availability of services from transgender individuals based on gender identity or diagnosis of gender dysphoria, while still offering those same services to cisgender individuals, may constitute discrimination under Michigan law. So that letter then also encouraged patients to consult with legal counsel to understand their rights and obligations under Michigan law and the impact of federal litigation challenging the federal government's efforts to block funding and limit health care access. So we've got a state saying, hey, providers, I know you're worried about what's happening at the federal level, but let me remind you that Michigan law protects these activities. On the flip side, then, in Alaska, we saw their medical board, the Alaska State Medical Board, pass a draft regulation that would allow medical providers to be sanctioned by the board for providing gender-affirming care to minors and would put their license at risk. So clearly, the states continue to be active in this space on both sides of the issue.
SPEAKER_02:That's, I mean, between the federal government and the states, that's so much for providers, not to mention patients, to deal with. So what are providers and patients doing with all of these Yeah.
SPEAKER_01:It's a really, you know, Adam, it's a really tense time for providers of gender affirming care. Those that believe in its merits are torn between the persistent and increasingly punitive actions of the federal government and what the providers feel is the right care for their transgender patients and the care that those patients are desperately seeking. Added to that is the impact of the laws in which the in the state in which the provider practices. In the restrictive states, we've got gender affirming care providers who must navigate those increasingly limiting state laws that are obviously robustly supported by the federal government. And then in states that provide support for gender affirming care, those providers must balance the growing federal restrictions with the pressure from their own state governments to continue to provide this care. So it's a lot for providers to navigate. And what we're starting to see increasingly is movement in the direction of discontinuing pediatric gender-affirming care. And note that discontinuing that care brings its own risks, including, as we mentioned, potential actions from state governments that support that care, but also from, to your point, Adam, families and patients that are impacted by discontinuance of this care. So the best that we can say to providers at this point is to make sure that they're working closely with their legal team and risk teams to stay up to date on state and federal actions and how they intersect with their provision of patient care, because it's changing daily and we don't really see an end in sight at this point. So understanding what's happening at the federal level and how that impacts your care and then what your state says is crucial to providers in this clinical space.
SPEAKER_02:Everything is changing. The federal laws are changing. The states have to react or the states are doing their own thing and the federal government is reacting. So, um, it's, it's, it's quite a bit of activity.
SPEAKER_01:It is. And, you know, it's, it's a challenge for us as lawyers to keep up with all of the activity and changes that I really have so much empathy for the providers and families in this space as they're trying to navigate provision of care, um, figure out what they can provide, figure out what's available to these patients. Um, and keep up on a daily basis. So it is a challenging time in this clinical space.
SPEAKER_02:Yeah. And I really appreciated your, you know, one of your final comments, which is to make sure that you're working closely with your legal and risk teams, you know, and however your organization or institution is configured to be working closely with those people who are also keeping an eye on things, but maybe have a focused on the patient care and not worrying about all these external factors. There are people, again, depending on your organization or institution, who do that, and you should lean on them if you're a clinician and you focus on doing the best you can for your patients.
SPEAKER_01:That's right. They're there to help you.
SPEAKER_02:Well, I would like to thank Jenny Nelson Carney for being a part of this podcast and contributing such a great body of knowledge on gender affirming care. It's obvious that she's been keeping up on this as we're all struggling to do. And thank the AHLA for inviting us to have this conversation again and giving us a platform to make this available to help everyone else who's hopefully trying to keep up with all these developments as well so jenny thank you so much and thank you everyone for joining us and have a great day thanks
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